Biotech Updates

US Court Overturns USDA Ruling on Genetically Engineered Plants

December 11, 2024

On December 2, 2024, the United States District Court for the Northern District of California, vacated the U.S. Department of Agriculture (USDA) final rule (7 CFR part 340) that was issued in May 2020 for organisms developed using genetic engineering (GE). Since May 2020, at least 99 GE plants have been exempted.

The said U.S. District Court sided with the National Family Farmers Coalition and other plaintiffs, ruling that the USDA's Animal & Plant Health Inspection Service (APHIS) made “significant errors” when it did not incorporate its noxious-weed authority in the final rule and implemented conventional breeding exemptions.

Before the final rule was issued in May 2020, USDA APHIS assessed the plant pest risk of each plant transformation event separately, even though the inserted genetic material is identical or very similar to previously assessed transformation events. Under the revised regulations, developers have the option of requesting a permit or a regulatory status review of a GE plant that has not been previously evaluated and determined to be nonregulated.

USDA APHIS is determining next steps and will provide additional guidance to stakeholders, and that Regulatory Status Review responses, Confirmation Request responses, and active permits issued prior to Dec. 2, 2024, remain valid.

For more details, read this article.


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